ASNC, ACC ask US government not to tariff radiopharmaceuticals
The presidents of the American Society of Nuclear Cardiology (ASNC) and the American College of Cardiology (ACC) sent a joint letter to the U.S. Department of Commerce urging a deferral of tariffs on radiopharmaceuticals and isotope-processing equipment so that patient access to nuclear imaging tests is not impacted.
They stressed that the U.S. healthcare system is currently extremely dependent on foreign supplies of radiopharmaceuticals, and despite more than a decade of attempts to ramp up U.S. production, barriers remain.
"We ask the administration to defer tariffs for radiopharmaceuticals, medical isotopes and specialized equipment needed to produce radiopharmaceuticals until a sufficient domestic supply can be established. This will ensure patients continue receiving optimal care from the nuclear cardiology community as efforts to establish domestic manufacturers across the United States continue," wrote ASNC President Panithaya Chareontaitawee, MD, and ACC President Christopher Kramer, MD.
ASNC said its priority remains limiting "deleterious effects" such as test inaccessibility or delays in appropriate testing to patients. Chareontaitawee said this could become an issue it supply is disrupted or if radiotracers become too expensive and insurance or Medicare payments can no longer cover the rising cost.
They were responding to a request for public comments on the impacts of tariffs and the vulnerabilities of the U.S. pharmaceutical industry due to imports. On April 16, public comments were requested through the Federal Register to help with the Secretary of Commerce’s investigation to determine the effects on the national security of imports of pharmaceuticals and pharmaceutical ingredients. This includes finished drug products, medical countermeasures, and active pharmaceutical ingredients (APIs). The agency is seeking comments about the impact of current trade policies on domestic production of pharmaceuticals and whether additional tariffs are necessary to protect national security. The Department of Commerce wants to better understand the current and projected U.S. demand for pharmaceuticals, the extent to which domestic production can meet domestic demand and the role of foreign supply chains.
Barriers to creating a domestic supply of radioisotopes
ACC and ASNC explained that radiopharmaceuticals used in cardiac imaging services are produced by suppliers in the European Union, Canada, Australia and South Africa, and are subject to a complex supply chain resulting from the short shelf-life isotopes that quickly decay.
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) also wrote a letter to the U.S. Department of Commerce, stating over 80% of diagnostic nuclear medicine procedures in the U.S. depend on technetium-99m (Tc-99m), which is produced from molybdenum-99 (Mo-99). Tc-99m is the primary radiotracer used in cardiac perfusion SPECT scans, and all of the Mo-99 used to produce it comes foreign nuclear reactors. SNMMI President Cathy Cutler, PhD, said the U.S. consumes more than half of the global Tc-99m supply, so trade stability is seen as an imperative for patients to receive lifesaving nuclear medicine imaging and therapies.
ASNC and SNMMI have both supported past efforts to onshore radiopharmaceutical production, including support of the American Medical Isotope Production Act (AMIPA), which Congress passed in 2012. AMIPA recognized the urgent need for domestic production of Mo-99 and the imperative of reducing reliance on foreign supplier. The program recruited companies and offered millions in grants to help kickstart U.S. production of Mo-99 made from low-enriched uranium sources.
"Despite the aims and efforts of AMIPA, there is still no domestic source of Mo-99 available because of barriers that confront manufacturers, including regulatory hurdles and cost," the ASNC/ACC letter states.
Over the past decade, public-private collaboration and $1 billion in public-private investment between industry and federal agencies have yielded no domestic production. The one company that did gain the extensive licensing required to start production, Wisconsin-based NorthStar, quickly ended Mo-99 production because it could not compete with the less expensive prices from from government-subsidized foreign reactors.
The only company left in the AMIPA program is Wisconsin-based Shine. It just purchased the SPECT division of Lathneus on May 7, which could signal movement on its future domestic production of Mo-99.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]